DOUGLAS E. DEMBLING
ASSOCIATE CHIEF OFFICER, OFFICE OF PUBLIC HEALTH &
VETERANS HEALTH ADMINISTRATION
DEPARTMENT OF VETERANS AFFAIRS
HOUSE COMMITTEE ON VETERANS' AFFAIRS
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
July 30, 2009
Good morning, Mr. Chairman, Ranking Member and committee members. Thank you for this opportunity to discuss the work of the Department of Veterans Affairs (VA) in studying the illnesses of Gulf War Veterans. I am accompanied today by Victoria Anne Cassano, MD, MPH, Acting Chief Consultant, Environmental Health Strategic Healthcare Group, Office of Public Health and Environmental Hazards, and David Barrans, Deputy Assistant General Counsel.
You have asked us to comment on VA’s statements of work with the National Academy of Sciences’ (NAS) Institute of Medicine (IOM) concerning Gulf War Veterans health issues and research. Specifically, you asked us to address issues raised about the utilization and consideration of animal studies by VA’s Research Advisory Committee (RAC) on Gulf War Veterans’ Illnesses. My testimony will provide background information about Gulf War Veterans, identify VA and IOM’s research findings and our actions based upon this information, review VA and IOM agreements with regard to animal studies, describe VA’s range of services and benefits for Gulf War Veterans, and outline federally sponsored research related to Gulf War Veterans.
The United States deployed nearly 700,000 military personnel to the Kuwaiti Theater of Operations (KTO) during Operations Desert Shield and Desert Storm (August 2, 1990, through July 31, 1991). Within months of their return, some Gulf War Veterans reported various symptoms and illnesses they believed were related to their service. Veterans, their families, and VA subsequently became concerned about the possible adverse health effects from various environmental exposures during Operations Desert Shield and Desert Storm. In response, in 1994, VA asked Congress for special authority, granted under the “Persian Gulf War Veterans’ Act,” Public Law 103-446, to provide compensation benefits to Gulf War Veterans who are chronically disabled by undiagnosed illnesses. That authority was later expanded to include certain illnesses of unknown cause. In 1995, VA implemented the “Persian Gulf War Veterans’ Act” by adding 38 C.F.R. § 3.317, which defines qualifying Gulf War service, establishes the presumptive period for service connection, and denotes certain signs and symptoms that may be manifestations of such illnesses. These signs and symptoms include: fatigue, skin signs or symptoms including hair loss, headache, muscle pain, joint pain; as well as neurologic, respiratory and cardiac signs or symptoms, abnormal weight loss and menstrual disorders. In addition, three medically unexplained multisystem illnesses’ namely, Chronic Fatigue Syndrome, Fibromyalgia and Irritable Bowel Syndrome, are currently recognized by both statute and regulation as “qualifying chronic disabilities” and thereby presumptively service connected based on Gulf War service.
Further, through the “Persian Gulf War Veterans Act of 1998,” Public Law 105-277, Congress authorized VA to compensate Gulf War Veterans for diagnosed or undiagnosed illnesses that are determined by VA to warrant a presumption of service connection based upon a positive association with exposure, as a result of Gulf War service, to a toxic agent, an environmental or wartime hazard, or a preventive medication or vaccine known or presumed to be associated with Gulf War service.
Of particular concern have been the illnesses that have eluded specific diagnosis. The latest VA study – Health of US Veterans of 1991 Gulf War: A Follow-Up Survey in 10 Years (published April 2009) – found that 25 percent more Gulf War Veterans reported suffering from unexplained multi-symptom illness than their Gulf War era military peers. Although the majority of Gulf War Veterans seeking VA health care have had readily diagnosable health conditions, we remain very concerned about Veterans whose symptoms have not been diagnosed. VA continues to compensate and treat these conditions even without a clear diagnosis.
VA and IOM Study Findings
As directed by Congress, VA has utilized IOM to evaluate potential associations between environmental hazards encountered during military deployment and specific health effects. The Agent Orange Act of 1991 (Public Law 102-4) directed VA to seek to enter into an agreement with NAS to review and summarize the scientific evidence concerning the association between exposure to herbicides used in support of military operations in Vietnam during the Vietnam Era and each disease suspected to be associated with such exposure. IOM’s work has allowed VA to recognize approximately a dozen diseases as presumed to be connected to exposure to Agent Orange and other herbicides used during the Vietnam War, which allows Veterans who were in theater during the relevant period to be compensated for these conditions without having to prove their connection to service.
In response to increased health concerns among Veterans of the 1991 Gulf War, Congress passed the Persian Gulf War Veterans Act of 1998 and again directed VA to enter into a similar agreement with NAS to review and evaluate the available scientific evidence regarding associations between illnesses and exposure to toxic agents, preventive medicines, vaccines, and environmental or wartime hazards associated with Gulf War service. This process has generated nine comprehensive IOM Committee reports on a wide variety of Gulf War health issues including assessments of long-term health effects from vaccines, depleted uranium, nerve agent antidotes, chemical warfare agents, pesticides, solvents, fuels, oil-well smoke, infectious diseases, deployment-related stress, traumatic brain injury, and Gulf War Veteran epidemiological studies.
IOM’s scientific assessments are regularly sought to address a range of health care issues. Their independent stature and collection of internationally recognized scholars, scientists, and researchers uniquely positions them to provide expert, well-informed objective findings. As Congress directed, VA contracts with IOM to obtain independent and objective professional opinions concerning available scientific evidence. When VA contracts with IOM, we defer to their professional opinions concerning methodology in order to maintain this independence. Their reports consider all available research, including both human and animal studies, to guide their findings about whether there is evidence of an association between exposure to a substance or hazard and the occurrence of an illness and whether there is a plausible biological mechanism or other evidence to support that connection. IOM bases their recommendations upon formal findings and scientific evidence, and their review process requires each IOM report to be reviewed internally and externally before release to VA and the public.
At the direction of Congress, VA, in 2002 chartered the Research Advisory Committee on Gulf War Veterans’ Illnesses to advise the Secretary on the overall effectiveness of federally-funded research to answer central questions on the nature, causes, and treatments of Gulf War Veterans’ illnesses. The RAC published and released reports in 2004 and again in 2008.
After the 2008 RAC report was released, VA requested that IOM explain discrepancies between the RAC’s report and findings contained in nine congressionally mandated IOM committee reports on Gulf War health issues completed since 1998. On January 23, 2009, VA received a response from Dr. Harvey Fineberg, President of the IOM, who noted:
“…that the RAC and the IOM committee that prepared Gulf War and Health Volume 4: Health Effects of Serving in the Gulf War agree that there is a multisymptom illness in Gulf War veterans. . . Thus both committees recognize increased occurrence of symptoms in Gulf War veterans.”
“.. The RAC attributes Gulf War illness to pyridostigmine bromide (PB) and pesticides, whereas the IOM committee did not link multisymptom illness to specific exposures.”
“While the RAC and IOM committees both recognize increased reporting of symptoms in Gulf War veterans, the IOM committees were not able to associate specific exposures with particular reported symptoms.”
In February 2009, Secretary Shinseki asked IOM to invite representatives of the RAC to describe the report and the basis of its findings to IOM to ensure that the basis for any differences between these reports are communicated and considered by the latest IOM committee. RAC members addressed the IOM committee at an open meeting on April 14, 2009, in Washington, D.C. The possibility that the RAC report reached different conclusions due to access to more recent scientific studies cannot be ruled out. This possibility should be answered in the current IOM full literature review on Gulf War Veterans’ health, which will be completed in February 2010.
VA and IOM Agreements Concerning Animal Studies
The major criticism by the RAC regarding the scientific process used by the IOM committees’ analyses is that IOM did not use animal studies to draw conclusions about the strength of association between outcome and exposure. Congress requires VA to contract with IOM for external scientific review of the accumulating science relevant to long-term health consequences of service in the Gulf War. IOM is an independent, world class, scientific organization that has extensive internal expertise and uses the world’s leading external scientists for these efforts. IOM puts all of their analyses through rigorous internal and external review, and VA relies on their opinion and continues to have confidence in the methods they use to conduct these assessments.
The RAC also has stated that VA inappropriately required IOM to not use animal studies in its various analyses. In reviewing all of the contracts for the nine IOM studies, there is no language in the Charges to the Committee or the Statements of Work that either requires or requests IOM to disregard animal studies. At the request of the House Veterans’ Affairs Oversight Committee, VA has provided all of the Statements of Work for both the Gulf War IOM studies and the Agent Orange IOM studies.
The standard procedure for all VA-contracted IOM committee studies is to leave each independent committee completely in charge of deciding what research to include and how to interpret it. VA relies fully upon the IOM committee’s independent scientific and medical expertise in determining how they will use both animal and human studies in their evaluations. VA’s formal charge to each IOM committee specifically requests they use all relevant data as they see fit.
In a January 24, 2003, letter, the Secretary of Veterans Affairs specifically asked IOM to review animal studies on health effects from the chemical warfare agent Sarin. This request was based on the fact that several published studies seemed to indicate a health effect of low-dose exposure to Sarin in animals. This request produced the 2004 IOM committee study, Gulf War & Health: Updated Literature Review of Sarin. That IOM committee reviewed human studies as well as over 100 animal studies as cited in the report, including several studies mentioned in the Secretary’s letter on the topic. The resulting VA Task Force report to the Secretary on this IOM report included the following analysis on this issue:
"The Committee also reported that the newly published data from experimental animals that had precipitated the interest in an updated study of sarin health effects [mentioned in Secretary Principi's letter to IOM] which were designed to mimic the potential exposures in the Gulf War, were an important step in 'determining whether a biologically plausible mechanism could underlie any long-term effects of low exposure to chemical nerve agents, but more work needs to be conducted to elucidate potential mechanisms and clarify how the cellular effects are related to any clinical effects that might be seen.'
"The IOM Committee and staff provided a briefing to VA on August 19, 2004. At that briefing, the issue was raised (by VA staff) that the IOM emphasis on human studies might overlook health concerns revealed only in laboratory animal studies. The IOM Committee chair acknowledged this concern, but also stated that the Committee did thoroughly review available animal studies, and concluded that taken together they failed to show consistent biological effects that could be plausibly tied to potential clinical effects in humans. He added that future animal studies might change that."
VA’s most recent charge to IOM was issued on January 27, 2009, and included this guidance: “…the goal of this exercise is to help us understand health issues among Veterans of the 1991 Gulf War. In carrying out your new charge, VA expects that you will make appropriate use of all the literature your committee considers to be relevant. That is, we expect that your committee exclusively will be the sole determiner on what literature must be reviewed to carry out your charge.”
VA does not select IOM committee members, and each IOM committee is completely at liberty to select the approach it will use in evaluating Gulf War Veteran health issues and the scientific literature it will use. After execution of the committee charge, VA has no contact with committee members until a report is finalized. The entire process normally takes 15 to 18 months.
VA Services and Benefits
Research is an important element of VA’s support for Veterans, but by turning information into action, VA directly improves the care of America’s heroes. VA trains its providers to prepare to respond to the specific health care needs of all Veterans, including Gulf War Veterans with difficult-to-diagnose illnesses. For Gulf War Veterans, VA developed a Clinical Practice Guideline on post-combat deployment health and dealing with diagnosis of unexplained pain and fatigue. Also, VA has three War Related Illness and Injury Study Centers (WRIISCs) to provide specialized health care for combat Veterans from all deployments who experience difficult to diagnose or undiagnosed but disabling illnesses. Starting in 2002, the WRIISCs began serving as referral centers for Veterans with undiagnosed or difficult to diagnose complaints. Veterans referred to the WRIISCs are provided with a complete exposure assessment, outpatient or inpatient evaluation (including advanced neurological evaluations), and a detailed treatment plan, which is provided to the Veterans’ VA primary care providers. Based on lessons learned from the Gulf War, VA realizes that concerns about unexplained illnesses could also emerge after Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) deployments, and we are building our understanding of such illnesses.
Following the Gulf War, VA developed the Veterans Health Initiative (VHI) Independent Study Guides for health care providers as one of many options to provide tailored care and support of Veterans. This Study Guide was principally designed for the clinical care of Veterans of that era, but has proven highly relevant for treating OEF/OIF Veterans since many of the hazardous deployment-related exposures are likely to be the same. VA developed other Independent Study Guides for health care providers to deliver appropriate care to returning Veterans from Iraq and Afghanistan that cover topics such as gender and health care, infectious diseases of Southwest Asia, military sexual trauma, and health effects from chemical, biological and radiological weapons. Study Guides on post-traumatic stress disorder and TBI were also developed and made available for primary care physicians to increase understanding and awareness of these conditions. VHIs are currently undergoing a comprehensive update which will both include the latest information and make them more accessible and modifiable than in the past. However, VHIs are only one resource for providers. Every VA medical center is required to have an environmental health clinician available to discuss any concerns Veterans or providers may have regarding combat theater exposures. VA distributes similar information to providers through newsletters, brochures, conference calls and the WRIISCs to educate providers to the unique needs of combat Veterans.
Federally Sponsored Research
VA takes the illnesses of Gulf War Veterans very seriously and has established a robust research program to study these illnesses. VA has spent over $20 million in support of research on Gulf War Veterans’ illnesses in both fiscal years (FY) 2007 and 2008. VA prepares an Annual Report to Congress that describes federally sponsored research on Gulf War Veterans’ Illnesses, and has done so every year since 1997. In the 2007 report, VA provided updated information on 19 research topics in five major research areas and a complete project listing by research focus area. The research areas include: brain and nervous system function, environmental toxicology, immune function, reproductive health, and symptoms and general health status. The 2007 report noted that between FY 1992 and FY 2007, VA, DoD, and the Department of Health and Human Services (HHS) funded 345 distinct projects related to health problems affecting Gulf War Veterans. Funding for this research on the health care needs of Gulf War Veterans has totaled nearly $350 million over this period of time. These projects varied from small pilot studies to large-scale epidemiological surveys. Nine projects were funded through the Gulf War Veterans’ Illnesses Research Program and three were funded through the Peer Reviewed Medical Research Program. Both programs are managed by the Congressionally Directed Medical Research Program at DoD. VA funded two new projects in FY 2007, with one focused on Environmental Toxicology and the other on Symptoms and General Health.
VA Secretaries have made full use of IOM committee reports in determining whether new presumptive service connections are warranted, as provided for in the statutes that underlie this process.
Mr. Chairman, Congress has directed VA to continue to utilize IOM’s independent evaluations of research when making determinations about Gulf War Veterans’ illnesses. IOM is a nationally recognized authority in analyzing clinical research and we rely on their ability to provide sound assessments.
Secretary Shinseki recognizes that this well established process takes time. He has therefore, asked VA staff to review this approach and determine if there are additional ways to uncover the data necessary to determine a connection between exposures in military service and specific health outcomes.
Thank you again for the opportunity to testify. My colleagues and I are prepared to address any questions you or the other committee members might have.